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  • Pre-evaluation Virology March 2017 20170512.doc 1 of 15

    Pre-evaluation of the External Quality Assessment Schemes in Virus Diagnostics

    March

    2017

    Prof. Dr. Heinz Zeichhardt

    Dr. Martin Kammel

    Issued by:

    INSTAND

    Gesellschaft zur Förderung

    der Qualitätssicherung

    in medizinischen Laboratorien e.V.

    Düsseldorf/Berlin, Germany, 12.05.2017

  • Pre-evaluation Virology March 2017 20170512.doc 2 of 15

    INSTAND EQA Schemes in Virus Diagnostics in cooperation with:

    Deutsche Vereinigung zur Bekämpfung der Viruskrankheiten e.V. (DVV)

    Gesellschaft für Virologie e.V. (GfV)

    Deutsche Gesellschaft für Hygiene und Mikrobiologie e.V. (DGHM)

    EQAS Adviser: Assistant EQAS Adviser: Prof. i. R. Dr. Heinz Zeichhardt Dr. Martin Kammel Charité - University Medicine Berlin c/o INSTAND e.V. Ubierstr. 20, 40223 Düsseldorf Correspondence address: Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Prof. Dr. Heinz Zeichhardt Email: M.Kammel@iqvd.de Institut für Qualitätssicherung in der Virusdiagnostik - IQVD Potsdamer Chaussee 80, D-14129 Berlin, Germany Tel.: +49-(0)30-81054-300; Fax: +49-(0)30-81054-303 Email: Heinz.Zeichhardt@iqvd.de

    Organisation and Logistics:

    INSTAND e.V. Ubierstr. 20 D-40223 Düsseldorf, Germany Tel.: +49 (0)211 - 1592 13 0 Fax: +49 (0)211 - 1592 1330 Email: instand@instand-ev.de Internet: www.instand-ev.de

    mailto:M.Kammel@iqvd.d mailto:Heinz.Zeichhardt@iqvd.d mailto:instand@instand-ev.de http://www.instand-ev.de/

  • Pre-evaluation Virology March 2017 20170512.doc 3 of 15

    Pre-Evaluation

    and Mailing of Participation Documents

    INSTAND External Quality Assessment Schemes – March 2017

    Virus Immunology Virus Genome Detection by PCR/NAT

    Dear colleagues,

    You have participated in one or several of the INSTAND external quality assessment (EQA) schemes in virus diagnostics of March 2017. Today you receive the pre-evaluation.

    By mail, you receive the following participation documents of those EQA schemes in which you have participated this time:

     certificate of successful participation  statement of participation  statement of individual results

    The EQA schemes having been performed in March 2017 are highlighted in bold in Tables 1 and 2. For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation. Please note: The below mentioned INSTAND EQA schemes were postponed to the second quarter of 2017 in order to consider new circulating virus variants for the corresponding panel (shipment date: 08 May 2017):

     Influenza viruses (genome / Ag) (370)

     Norovirus (381)

    Table 1: EQA schemes performed with a frequency of four times per year

    VIRUS IMMUNOLOGY:

    Cytomegalovirus (351) Hepatitis A virus (343) Hepatitis B virus Prog. 1 (344) Hepatitis B virus Prog. 2 (345) Hepatitis C virus (346) HIV-1/HIV-2 (335) HIV-1 p24 Ag (337)

    VIRUS GENOME DETECTION:

    Cytomegalovirus (365) Hepatitis A virus (377) Hepatitis B virus (361) Hepatitis C virus (362) HIV-1 (RNA) (360) Parvovirus B19 (367)

    The EQA schemes having been performed in March 2017 are highlighted in bold (Table 1). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with this pre-evaluation.

  • Pre-evaluation Virology March 2017 20170512.doc 4 of 15

    Table 2: EQA schemes performed twice per year or with lower frequency (EQA schemes having been performed in March 2017 are highlighted in bold)

    VIRUS IMMUNOLOGY:

    Chikungunya virus (402) Dengue viruses (Ab/NS1-Ag) (350) Epstein Barr virus (352) TBE (FSME) virus (358) Hantaviruses (355) Hepatitis D virus (347) Hepatitis E virus (348) Herpes simplex viruses (354) HTLV-1/HTLV-2 (339) Measles virus (357) Mumps virus (356) Parvovirus B19 (342) Rubella virus (341) Rabies (Tollwut) virus (336) Varicella zoster virus (353) Zika virus (338)

    VIRUS GENOME DETECTION:

    Adenoviruses (371) BK virus (364) Chikungunya virus (392) Coronaviruses (340) Cytomegalovirus training program (368) Cytomegalovirus resistance determination (349) Dengue viruses (369) Enteroviruses (372) RKI-Entero-Surveillance (every two years) (374) Epstein Barr virus (376) Hepatitis B virus training program (378) Hepatitis B virus genotyping (396) Hepatitis B virus resistance determination (397) Hepatitis C virus training program (379) Hepatitis C virus geno-/subtyping (375) Hepatitis C virus resistance determination (399) Hepatitis D virus (400) Hepatitis E virus (380) Herpes simplex virus type 1/2 (363) HIV-1 (RNA) training program (382) HIV-1 drug resistance determ. (standard progr.) (383) HIV-1 drug resistance determ. (additional progr.) (384) HIV-2 (RNA) (395) Human Metapneumovirus (385) Human Papilloma viruses (373) Human Rhinoviruses (393) Influenza viruses (genome/Ag) (370)* JC virus (394) Measles virus (386) Mumps virus (387) Norovirus (381)* Parainfluenza viruses (388) Respiratory syncytial virus (Ag/genome) (359) Rotaviruses (401) Rubella virus (389) Rabies (Tollwut) virus (390) Varicella zoster virus (366) West Nile virus (391) Zika virus (403)

    * The INSTAND EQA schemes Influenza viruses (genome / Ag) (370) and Norovirus (381) were postponed to the second quarter of 2017 in order to consider new circulating virus variants for the corresponding panel (shipment date: 08 May 2017).

    The EQA schemes having been performed in March 2017 are highlighted in bold (Table 2). For these highlighted EQA schemes, the corresponding participation documents will be sent out by mail together with

    EQA schemes in Table 2 marked in italics were not performed in March 2017.

    Please see the following Tables 3, 4 and 5 for details on sample properties and the expected target values for this EQA scheme March 2017. You received information on sample properties already per email on 18.04.2017.

    The reports of all EQA schemes will be released on the INSTAND homepage immediately after completion. For details please see the INSTAND homepage under "EQAS Online / Service for EQA tests / EQA area (Virus immunology / Virus genome detection)" in English language: http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html and in German language: http://www.instand-ev.de/ringversuche-online/ringversuche-service.html.

    http://www.instand-ev.de/en/eqas-online/service-for-eqa-tests.html http://www.instand-ev.de/ringversuche-online/ringversuche-service.html

  • Pre-evaluation Virology March 2017 20170512.doc 5 of 15

    Please note:

     RiliBÄK A compilation of the "Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesärztekammer / RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen)" with all Sections including Section B 2 "Qualitative medical laboratory testing = Qualitative laboratoriumsmedizinische Untersuchungen" and Section B 3 "Direct detection and characterisation of infectious agents = Direkter Nachweis und Charakterisierung von Infektionserregern" has recently been published (in German language: Deutsches Ärzteblatt, Jg. 111, Heft 38, 19. September 2014, A 1583 - A 1618) (please see link).

    An English version of the guideline translated by INSTAND e.V. with the consent of the Executive Board of the German Medical Association has been published in "German Medical Science" [in English language: Bundesärztekammer (German Medical Association), Instand e.V., Guidelines of the German Medical Association on quality assurance in medical laboratory testing. GMS Z Forder Qualitatssich Med Lab. 2015; 6] (please see link).

    Notice for German laboratories: The requirements laid down in Specified Section B 3 - effective since 01.04.2013 and with a transition period until 31.05.2015 - should now be fulfilled.

     INSTAND EQA schemes in virus diagnostics and INSTAND ordering documents 2017 For details please see the INSTAND ordering documents 2017 incl. brochure and order form (please see link).

     Additional training programs in virus genome detection Additional training programs were provided for the sixth time with the EQAS term March 2017.

    Cytomegalovirus (368) Hepatitis B virus (378) Hepatitis C virus (379) HIV-1 (RNA) (382)

    Please note: Additional training programs for virus genome detection of CMV, HBV, HCV and HIV-1 (RNA), respectively, containing low virus concentrations, are offered once only in March. The integration of the previous EQA scheme terms (March and September) will make it possible to evaluate a larger number of analyses with improved statistics.

    A training program contains low-concentration samples for each of the viruses to verify test sensitivities. The low-concentration samples are used as a complement to the respective main EQA scheme and contain samples with virus concentrations within the requirements of the new Guidelines of the German Medical Association on quality assurance in medical laboratory testing (Bundesärztekammer/RiliBÄK = Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen) as specified in Table B 3-2a of the RiliBÄK.

    Please note: A training program can only be ord